This course – LC-MS Method Validation – is a practice-oriented on-line course on validation of analytical methods, specifically using LC-MS as technique. The course introduces the main concepts and mathematical apparatus of validation, covers the most important method performance parameters and ways of estimating them. The course is largely based on the recently published two-part tutorial review:
Tutorial review on validation of liquid chromatography–mass spectrometry methods: Part I. A. Kruve, R. Rebane, K. Kipper, M.-L. Oldekop, H. Evard, K. Herodes, P. Ravio, I. Leito. Anal. Chim. Acta 2015, 870, 29-44 Tutorial review on validation of liquid chromatography–mass spectrometry methods: Part II. A. Kruve, R. Rebane, K. Kipper, M.-L. Oldekop, H. Evard, K. Herodes, P. Ravio, I. Leito. Anal. Chim. Acta 2015, 870, 8-28
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The course contains:
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Course introduction
1. Validation: General
2. Selectivity and identity confirmation
2.1. Selectivity: LC selectivity
Self-test 2.1
2.2. Selectivity: detector-side (MS) selectivity
Self test 2.2
2.3. Selectivity examples
2.4. Introduction to identity confirmation
Self test 2.4
2.5. Identity confirmation: retention time
2.6. Identity confirmation by MS
2.7. Identity confirmation examples
Self test 2.7
3. Linearity of signal, linear range, sensitivity
4. Precision
5. Trueness
6. Precision and trueness: some additional aspects
7. Accuracy
8. Stability
9. LoD and LoQ
10. Ruggedness, robustness
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